Specialized Workshop M2 - Monday April 13, 2026: 7am to 5:30pm
"AGENDA - Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"
| 07:00am-08:00am: | Start your day at WRIB with Continental Breakfast |
Session 1: Overcoming Sample Collection/Stability Issues during BAV & Clinical Biomarker Analysis
Chair: Dr. Markus Dudek, Lab Head Functional Biomarkers, Sanofi| 08:00am-08:20am: |
Dr. Steve Keller, Senior Director Biomarker Bioanalysis , AbbVie "Microsampling for biologic drug and biomarker evaluation" |
| 08:20am-08:40am: |
Dr. Nicoletta Bivi, Senior Director Clinical Biomarkers, Lilly "Adaptive Sample Handling Strategies for Reliable HbA1c Results in Diverse Clinical Trial Environments" |
| 08:40am-09:00am: |
Dr. Eric Tewalt, Director Clinical Biomarkers, Ionis "Biomarker Validation and Clinical Testing in Rare Neurological Diseases: Lessons Learned and Emerging Strategies" |
| 09:00am-09:20am: |
Dr. Steve Keller, Senior Director Biomarker Bioanalysis , AbbVie
Dr. Nicoletta Bivi, Senior Director Clinical Biomarkers, Lilly Dr. Eric Tewalt, Director Clinical Biomarkers, Ionis "Panel Discussions on Overcoming Sample Collection/Stability Issues during BAV & Clinical Biomarker Analysis" |
| 09:20am-09:50am: | Coffee Break with Morning Snacks |
Session 2: Sophisticated IVD & CDx Assay Strategies to meet Regulatory Requirements
Chair: Dr. Kristina McGuire, Executive Director, Head of Clinical Diagnostics & Clinical Laboratory Operations, Regeneron| 09:50am-10:10am: |
Dr. Fei Wu, Senior Director Clinical Biomarkers, Moderna "A Pragmatic Approach to Deploying Methylmalonic Acid Assays for Patient Stratification and Biomarker Assessment in a Pivotal Rare Disease Clinical Study" |
| 10:10am-10:30am: |
Dr. Ming Li, Associate Director Translational Medicine, Alexion "Development and Validation of a KM55-Based Ligand Binding Assay for Quantification of Galactose-Deficient IgA1" |
| 10:30am-10:50am: |
Dr. Melis McHenry, Associate Director Precision Medicine Companion Diagnostics , Regeneron "Establishing Threshold for Pre-Existing Anti-AAV Antibody Levels in Gene Therapy Clinical Trials" |
| 10:50am-11:10am: |
Dr. Fei Wu, Senior Director Clinical Biomarkers, Moderna
Dr. Ming Li, Associate Director Translational Medicine, Alexion Dr. Melis McHenry, Associate Director Precision Medicine Companion Diagnostics , Regeneron "Panel Discussions on Sophisticated IVD & CDx Assay Strategies to meet Regulatory Requirements " |
Special Session: ASK THE REGULATORS!
| 11:10am-11:50am: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Biomarkers & CDx/BAV Regulatory Panelists:
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| 11:50am-12:50pm: | Sit-down Hot Buffet Lunch downstairs at Marsalis B |
Session 3: COU Limitations & Enhanced Solutions for Overcoming Issues in Complex Biomarkers Development
Chair: Dr. Lindsay King, Executive Director, Head of Translational & Clinical Biomarkers, Pfizer| 12:50pm-01:10pm: |
Dr. Hiroshi Sugimoto, Director Translational Biomarker & Bioanalysis, Takeda "Fit-for-purpose small molecule neurodegenerative disease biomarker assay development, validation and its application in clinical study" |
| 01:10pm-01:30pm: |
Mr. Joel Mathews, Director Biomarker Research, Ionis "Current challenges to achieve tissue enrichment and assay sensitivity in biomarker assay development – extracellular vesicles" |
| 01:30pm-01:50pm: |
Mr. Huidong (Ryan) Gu, Associate Director Bioanalysis & Translational Mass Spectrometry , Bristol Myers Squibb "A Novel Approach for Generating Antigen Interference-Free Anti-Peptide Polyclonal Antibodies for Quantitative Measurements of Low-Abundance Protein Biomarkers Using Ultra-Sensitive Anti-Peptide Immunocapture LC-MS/MS Assays" |
| 01:50pm-02:10pm: |
Dr. Hiroshi Sugimoto, Director Translational Biomarker & Bioanalysis, Takeda
Mr. Joel Mathews, Director Biomarker Research, Ionis Mr. Huidong (Ryan) Gu, Associate Director Bioanalysis & Translational Mass Spectrometry , Bristol Myers Squibb "Panel Discussions on COU Limitations & Enhanced Solutions for Overcoming Issues in Complex Biomarkers Development " |
Session 4: Novel/Alternative Approaches in FFP BAV: Linearity, Automation, Cross-validation, Singlicate
Chair: Dr. Jasdeep Nanra , Executive Director Assay Development & Innovation, GlaxoSmithKline| 02:10pm-02:30pm: |
Mr. Francis Dessy, Director Assay Development & Innovation, GlaxoSmithKline "Defining vaccine immunogenicity assay linearity criterion in a multiplex assay" |
| 02:30pm-02:50pm: |
Dr. Liang Zhu, Director Clinical Biomarker Laboratories, Moderna "Qualification, Clinical Performance, and Future Autonomy of Automated Singlicate Ligand Binding Assays." |
| 02:50pm-03:20pm: | Coffee Break with Afternoon Snacks |
| 03:20pm-03:40pm: |
Dr. Andria Culbert, Associate Director Immunoassay PK & Soluble Biomarker , GlaxoSmithKline "From Calibrator Challenges to Cross‑Lab Comparison: A Total Biomarker Assay Case Study" |
| 03:40pm-04:00pm: |
Dr. Andrei Avanesov, Associate Director Clinical Biomarker Assay Development, Moderna "HAI Singlicate Testing in Influenza Vaccine Studies: Benefits, Limitations, and Practical Considerations" |
| 04:00pm-04:20pm: |
Mr. Francis Dessy, Director Assay Development & Innovation, GlaxoSmithKline
Dr. Liang Zhu, Director Clinical Biomarker Laboratories, Moderna Dr. Andria Culbert, Associate Director Immunoassay PK & Soluble Biomarker , GlaxoSmithKline Dr. Andrei Avanesov, Associate Director Clinical Biomarker Assay Development, Moderna "Panel Discussions on Novel/Alternative Approaches in FFP BAV: Linearity, Automation, Cross-validation, Singlicate" |
Session 5: 2026 White Paper in Bioanalysis
| 04:20pm-05:20pm: |
Dr. Markus Dudek, Lab Head Functional Biomarkers, Sanofi Dr. Kristina McGuire, Executive Director, Head of Clinical Diagnostics & Clinical Laboratory Operations, Regeneron Dr. Lindsay King, Executive Director, Head of Translational & Clinical Biomarkers, Pfizer Dr. Jasdeep Nanra , Executive Director Assay Development & Innovation, GlaxoSmithKline "Recommendations on Biomarkers & Companion Diagnostics and Panel Discussions for 2026 White Paper in Bioanalysis" |
| 05:30pm-06:30pm |
Welcome Reception at Reunion Ballroom Foyer
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